MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 PERCUTANEOUS STIMULATION LEAD

Model Number 8145

Device Problem Failure to Conduct (1114)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that the patient underwent revision surgery to replace the reactiv8 system due to the progression of the right lead's out-of-range/high impedance failure over time.The left lead had an out-of-range/high impedance on one electrode but was functional.The left lead and the implantable pulse generator (ipg) were functional but were replaced at the surgeon's discretion.The ipg and left lead were removed intact.The right lead was removed, but the tip was left inside the patient at the surgeon's preference.A new reactiv8 system was implanted with no report of patient harm or injury.

Manufacturer Narrative

Mml reference #: (b)(4).

Manufacturer Narrative

Mml reference # (b)(4).The ipg and two leads were returned for analysis.The ipg passed the functional test.Analysis confirmed lead conductor fractures were the cause of the out-of-range/high impedance conditions observed with the right percutaneous stimulation lead.The left lead failed the functional test.Circuit 2 was open, and visual inspection confirmed a broken wire.The reported issue was verified.Added other device explanted below.Model: 5100; description: reactiv8 implantable pulse generator, serial number: (b)(6), udi: (b)(4).Model: 8145; description: reactiv8 implantable stimulation lead, serial number: (b)(6), udi: (b)(4).

Event Description

It was reported that the patient underwent revision surgery to replace the reactiv8 system due to the progression of the right lead's out-of-range/high impedance failure over time.The left lead had an out-of-range/high impedance on one electrode but was functional.The left lead and the implantable pulse generator (ipg) were functional but were replaced at the surgeon's discretion due to the right lead being broken.The ipg and left lead were removed intact.The right lead was removed, but the tip was left inside the patient at the surgeon's preference.A new reactiv8 system was implanted with no report of patient harm or injury.

Manufacturer Narrative

Mml reference # (b)(4) the ipg and two leads were returned for analysis.The ipg passed the functional test.Analysis confirmed lead conductor fractures were the cause of the out-of-range/high impedance conditions observed with the right percutaneous stimulation lead.The left lead failed the functional test.Circuit 2 was open, and visual inspection confirmed a broken wire.The reported issue was verified.Updated h6 codes and b5.

Event Description

It was reported that the patient underwent revision surgery to replace the reactiv8 system due to the progression of the right lead's out-of-range/high impedance failure over time.The left lead had an out-of-range/high impedance on one electrode but was functional.The left lead and the implantable pulse generator (ipg) were functional but were replaced at the surgeon's discretion due to the right lead being broken.The ipg and left lead were removed intact.The right lead was removed, but the tip was left inside the patient at the surgeon's preference.A new reactiv8 system was implanted with no report of patient harm or injury.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 PERCUTANEOUS STIMULATION LEAD
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18302074
• MDR Text Key: 330177249
• Report Number: 3013017877-2023-00056
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8145
• Device Catalogue Number: 8145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White